This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Naproxen and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (784)
Death (188)
Life Threatening Events (80)
Disability (20)
Reports by Reaction Type
Completed Suicide (120),
Gastrointestinal Haemorrhage (71),
Haemoglobin Decreased (51),
Toxicity To Various Agents (46),
Dizziness (40),
Nausea (39),
Gastric Ulcer (38),
Diarrhoea (36),
Cardiac Arrest (33),
Dyspnoea (31),
Rash (30),
Haematemesis (28)
Below are a few examples of reports where side effects / adverse reactions may be related to Naproxen. For a complete list or a specific selection of reports, please use the links above.
Possible Naproxen side effects in 66 year old female
Reported by a pharmacist from United Kingdom on 2012-08-27
Patient: 66 year old female, weighing 110.0 kg (242.0 pounds)
Reactions: Duodenal Ulcer Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Bendroflumethiazide; Bisoprolol Fumarate; Dothiepin Hydrochloride; Ramipril
Possible Naproxen side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-26
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Swelling, DRY Mouth, Feeling Hot, Insomnia, Salmonellosis, Gait Disturbance, Blister
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Naproxen
Dosage: 2 df, unk
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Voltaren
Dosage: applied no more than 6 times
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Naproxen side effects in 62 year old male
Reported by a physician from France on 2012-08-24
Patient: 62 year old male
Reactions: Drug Interaction, Status Epilepticus
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient possibly interacting with the suspect drug: Depakene
Administration route: Oral
Start date: 2011-01-01
Depakene
Administration route: Oral
Indication: Idiopathic Generalised Epilepsy
Start date: 2009-01-01
Nexium
Administration route: Oral
Indication: Antiinflammatory Therapy
Start date: 2011-09-23
End date: 2011-09-23
Possible Naproxen side effects in 33 year old male
Reported by a physician from United States on 2012-08-24
Patient: 33 year old male
Reactions: Kounis Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-24
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Feeling Hot, DRY Mouth, Insomnia, Swelling, Salmonellosis, Gait Disturbance, Blister
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Naproxen
Dosage: 1 df, unk
Administration route: Oral
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Naproxen
Indication: Pain
Voltaren
Indication: Pain
Voltaren
Dosage: bid
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Naproxen side effects in 80 year old female
Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-08-24
Patient: 80 year old female
Reactions: Thrombosis, Fluid Overload, Dyspnoea, Vomiting, Tachycardia, Gastric Ulcer Haemorrhage, Hyperhidrosis, Abdominal Pain Upper, Haemodynamic Instability, Haematochezia, Cardio-Respiratory Arrest, Tachypnoea, Melaena, Blood Pressure Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient:
Reactions: Haemorrhage, Drug Interaction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Amoxicillin
Indication: Product Used FOR Unknown Indication
Amoxicillin and Clavulanate Potassium
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ciprofloxacin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Clopidegrel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Diclofenac Sodium
Indication: Product Used FOR Unknown Indication
Ibuprofen
Indication: Product Used FOR Unknown Indication
Ketoprofen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Levofloxacin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Marcumar
Dosage: unk
Indication: Product Used FOR Unknown Indication
Metronidazole
Indication: Product Used FOR Unknown Indication
Moxifloxacin
Indication: Product Used FOR Unknown Indication
Naproxen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ofloxacin
Indication: Product Used FOR Unknown Indication
Sulfamethoxazole Trimethoprim
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient:
Reactions: Adverse Event, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Bisacodyl
Indication: Product Used FOR Unknown Indication
Darunavir Ethanolate
Indication: Product Used FOR Unknown Indication
Erythromycin
Indication: Product Used FOR Unknown Indication
Famotidine
Indication: Product Used FOR Unknown Indication
Fluconazole
Indication: Product Used FOR Unknown Indication
Griseofulvin
Indication: Product Used FOR Unknown Indication
Indomethacin
Indication: Product Used FOR Unknown Indication
Ketoprofen
Indication: Product Used FOR Unknown Indication
Levofloxacin
Indication: Product Used FOR Unknown Indication
Naproxen
Indication: Product Used FOR Unknown Indication
Ofloxacin
Indication: Product Used FOR Unknown Indication
Tramadol HCL
Indication: Product Used FOR Unknown Indication
Possible Naproxen side effects in 33 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 33 year old male
Reactions: Kounis Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Feeling Hot, DRY Mouth, Swelling, Insomnia, Salmonellosis, Gait Disturbance, Blister
Drug(s) suspected as cause:
Naproxen
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Voltarol Emulgel
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Naproxen side effects in 33 year old male
Reported by a physician from United States on 2012-08-21
Patient: 33 year old male
Reactions: Kounis Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 76 year old female
Reported by a pharmacist from United States on 2012-08-20
Patient: 76 year old female
Reactions: Blood Urine Present
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Toprol-XL; Tylenol; Multi-Vitamin; Maxzide; Senna; Miralax; Dilaudid; Megace; Iron Supplement; Sutent
Possible Naproxen side effects in 40 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-20
Patient: 40 year old female, weighing 69.9 kg (153.8 pounds)
Reactions: Burning Sensation, Abdominal Pain, Diarrhoea, Swelling, Abdominal Distension
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Plavix
Possible Naproxen side effects in male
Reported by a consumer/non-health professional from Italy on 2012-08-17
Patient: male
Reactions: Pyrexia, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Esomeprazole Sodium
Dosage: one dosage unit (total)
Indication: Pharyngitis
Start date: 2012-07-03
End date: 2012-07-03
Naproxen
Dosage: one dosage unit (total)
Administration route: Oral
Indication: Pharyngitis
Start date: 2012-07-03
End date: 2012-07-03
Possible Naproxen side effects in male
Reported by a consumer/non-health professional from Israel on 2012-08-17
Patient: male
Reactions: Rash, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Esomeprazole Sodium
Dosage: one dosage unit (total)
Indication: Pharyngitis
Start date: 2012-07-03
End date: 2012-07-03
Naproxen
Dosage: one dosage unit (total)
Administration route: Oral
Indication: Pharyngitis
Start date: 2012-07-03
End date: 2012-07-03
Possible Naproxen side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-17
Patient: 60 year old female
Reactions: Toxic Epidermal Necrolysis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16
Patient: 40 year old female, weighing 69.8 kg (153.7 pounds)
Reactions: Abdominal Pain, Burning Sensation, Diarrhoea, Swelling, Abdominal Distension
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Plavix
Possible Naproxen side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-15
Patient: male, weighing 42.0 kg (92.4 pounds)
Reactions: Phlebitis, Off Label Use, Thrombosis, Tachycardia, Dizziness
Drug(s) suspected as cause:
Naproxen
Indication: Thrombosis
Xarelto
Administration route: Oral
Indication: Deep Vein Thrombosis
Start date: 2012-04-25
End date: 2012-05-04
Other drugs received by patient: Warfarin Sodium; Acetaminophen; Dipyrone INJ
Possible Naproxen side effects in male
Reported by a physician from Argentina on 2012-08-15
Patient: male
Reactions: Renal Tubular Necrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Adalimumab OR Placebo
Dosage: 40 milligram daily;
Indication: Rheumatoid Arthritis
Start date: 2012-04-09
End date: 2012-06-05
BMS 945429 OR Placebo
Indication: Rheumatoid Arthritis
Start date: 2012-04-09
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-04-09
Naproxen
Dosage: 1000 milligram daily;
Indication: Rheumatoid Arthritis
Other drugs received by patient: Prednisone TAB; Folic Acid
Possible Naproxen side effects in 57 year old female
Reported by a physician from United States on 2012-08-15
Patient: 57 year old female, weighing 69.0 kg (151.8 pounds)
Reactions: Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Subject Drug
Dosage: thrice a day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-03-07
Blinded NO Subject Drug
Indication: Rheumatoid Arthritis
Celecoxib
Indication: Rheumatoid Arthritis
Celecoxib
Dosage: thrice a day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-03-07
Ibuprofen
Dosage: thrice a day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-03-07
Ibuprofen
Indication: Rheumatoid Arthritis
Ibuprofen
Ibuprofen
Dosage: 200 mg, as needed
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-07-01
Ibuprofen
Dosage: thrice a day
Administration route: Oral
Start date: 2012-03-07
Naproxen
Indication: Rheumatoid Arthritis
Naproxen
Naproxen
Dosage: thrice a day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-03-07
Naproxen
Dosage: thrice a day
Administration route: Oral
Start date: 2012-03-07
Placebo
Indication: Rheumatoid Arthritis
Placebo
Dosage: thrice a day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2012-03-07
Other drugs received by patient: Nexium
Possible Naproxen side effects in 33 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14
Patient: 33 year old male
Reactions: Electrocardiogram ST Segment Depression, Angina Pectoris, Hypotension, Kounis Syndrome, Dizziness, Rash Maculo-Papular, Myocardial Infarction, Rash Pruritic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 66 year old male
Reported by a pharmacist from United States on 2012-08-14
Patient: 66 year old male, weighing 60.7 kg (133.5 pounds)
Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Haematocrit Decreased, Dialysis, Duodenal Ulcer Haemorrhage, Gastric Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 69 year old male
Reported by a pharmacist from Israel on 2012-08-14
Patient: 69 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Haemoglobin Decreased, Duodenal Ulcer Perforation, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Baclofen; Zopiclone; Fentanyl; Pregabalin
Possible Naproxen side effects in 18 year old female
Reported by a physician from United States on 2012-08-14
Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)
Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lamictal
Indication: Anger
Lamictal
Indication: Bipolar I Disorder
Lamictal
Dosage: 50 mg, extended tab
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2012-02-23
End date: 2012-03-08
Naproxen
Dosage: 500 mg, as needed
Indication: Ligament Sprain
Start date: 2012-02-22
Zithromax
Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
Administration route: Oral
Indication: Sinusitis
Start date: 2012-03-07
End date: 2012-03-09
Other drugs received by patient: Flexeril
Possible Naproxen side effects in 18 year old female
Reported by a physician from United States on 2012-08-14
Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)
Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lamictal
Dosage: 50 mg, extended tab
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2012-02-23
End date: 2012-03-08
Lamictal
Indication: Bipolar I Disorder
Lamictal
Indication: Anger
Naproxen
Dosage: 500 mg, as needed
Indication: Ligament Sprain
Start date: 2012-02-22
Zithromax
Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
Administration route: Oral
Indication: Sinusitis
Start date: 2012-03-07
End date: 2012-03-09
Other drugs received by patient: Flexeril
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13
Patient: 75 year old male
Reactions: Blood Creatinine Increased, Renal Failure Acute, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Finasteride; Simvastatin; Warfarin Sodium; Alfuzosin; Metformin Hydrochloride; Omeprazole
Possible Naproxen side effects in 40 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-13
Patient: 40 year old female, weighing 69.8 kg (153.7 pounds)
Reactions: Burning Sensation, Abdominal Pain, Diarrhoea, Swelling, Abdominal Distension
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Plavix
Possible Naproxen side effects in 96 year old male
Reported by a physician from United States on 2012-08-09
Patient: 96 year old male
Reactions: Abdominal Discomfort, Drug Ineffective, Gout, Diarrhoea, Diarrhoea Haemorrhagic, Laceration, Condition Aggravated, Abdominal Pain Upper
Drug(s) suspected as cause:
Flector
Indication: Pain in Extremity
Flector
Dosage: unk
Indication: Swelling
Flector
Dosage: unk
Indication: Arthralgia
Start date: 2012-06-19
Naproxen
Dosage: 500 mg, unk
Naproxen
Dosage: 500 ml, 2x/day
Start date: 2012-06-18
Other drugs received by patient: Diovan HCT; Levothyroxine; Xanax; Plavix; Lipitor; Hydroxyurea; Zegerid
Possible Naproxen side effects in 40 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-09
Patient: 40 year old female, weighing 69.8 kg (153.7 pounds)
Reactions: Burning Sensation, Abdominal Pain, Diarrhoea, Swelling, Abdominal Distension
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Plavix
Possible Naproxen side effects in 75 year old male
Reported by a pharmacist on 2012-08-09
Patient: 75 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Metfformin Hydrochloride; Warfarin Sodium; Omeprazole; Finasteride; Alfuzosin HCL; Simvastatin
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